Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer

NCT04632459 | Unknown Phase 2

• 1 other identifier: 2020-03-115
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

• Best Overall Response Rate: BORR
• Disease Control Rate: DCR
• Progression-Free Survival:PFS
• Overall Survival: OS
• Duration of Overall Response: DOR \& maximal tumor shrinkage
• Subjects : Patients with metastatic gastric or GEJ adenocarcinoma
• Study design(Dosage \& Treatment) Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
• Ramucirumab 8mg/kg on q2W
• Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
• If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria

  up to 24months

Secondary Outcomes (1)

• Best Overall Response Rate (ORR)

  24months

Study Arms (1)

pembrolizumab plus ramucirumab

EXPERIMENTAL

* Ramucirumab 8mg/kg on q2W * Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) * If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles

Drug: pembrolizumab plus ramucirumab

Interventions

pembrolizumab plus ramucirumab DRUG

Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria. * Ramucirumab 8mg/kg on q2W * Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) * If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.

pembrolizumab plus ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is ≥18 years of age.
• The patient who has received an adequate information and provided informed consent for all the study-specific procedures in advance
• The patient has histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma. (Patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) patient has metastatic disease or locally recurrent, unresectable disease.
• The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+ or PDL1 CPS≥10
• The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
• The patient has experienced disease progression during first-line treatment or second-line therapy for metastatic disease
• Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum and/or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-FU, capecitabine, or S-1). Regimens including a third agent, such as an anthracycline or a taxane, are acceptable provided a fluoropyrimidine and/or a platinum were used.
• Recurrence during or within 6 months of completion of adjuvant chemotherapy (capecitabine, 5-FU, or TS-1) will be considered as first-line chemotherapy.
• No prior exposure to anti-PD1 antibody or ramucirumab
• the patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
• Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥100 x 109/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST (SGOT)/ALT (SGPT) ≤ 3.0 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN Serum creatinine ≤1.5 x institutional ULN urinary protein is ≤1+ on dipstick or routine urinalysis (INR) ≤1.5 and (PTT) ≤5 seconds above the ULN (unless receiving anticoagulation therapy). Patients on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible
• Female patients of childbearing potential must have a negative pregnancy test (urine or serum), must not be breastfeeding and using adequate contraceptive measures.
• Female patients must use a highly effective contraceptive measure from screening until 90 days after the last dose of drug. All methods of contraception (except for total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse (see Restrictions below). (or vasectomy)
• Female patients must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:

You may not qualify if:

• The patient has documented and/or symptomatic encephalitis, brain or leptomeningeal metastases.
• The patient has experienced any Grade 3 to 4 GI bleeding within 3 months prior to enrollment.
• The patient has experienced myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment.
• The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy.
• The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the treating physician.
• The patient has ongoing or active psychiatric illness or social situation that would limit compliance with treatment
• The patient has uncontrolled or poorly controlled hypertension (\>160 mmHg systolic or \>100 mmHg diastolic for \>4 weeks) despite standard medical management.
• The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
• The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to enrollment.
• The patient has received any investigational therapy within 30 days prior to enrollment.
• The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment.
• The patient has received prior therapy with an agent that directly inhibits VEGF (including bevacizumab), or VEGF Receptor 2 activity, or any antiangiogenic agent and immunotherapy.
• The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs; including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
• The patient has a known allergy to any of the treatment components.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

pembrolizumab; Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jeeyun Lee, PhMD

CONTACT

82-2-3140-3459; jyun.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Model Details: Pembrolizumab Plus Ramucirumab

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: November 17, 2020
• Study Start: June 16, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)